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Increasing Engagement With Digital Behavioral Health

17. september 2026 opdateret af: Hackensack Meridian Health

Development of a Peer Digital Coach Intervention to Increase Adolescent and Young Adult Cancer Survivors' Engagement With a Digital Behavioral Health Intervention

This is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Phase 1 is a formative qualitative study designed to identify survivor-reported needs and preferences for increasing engagement with a mindfulness meditation app. Phase 2 is a pilot intervention study that will examine the feasibility, acceptability, and preliminary engagement outcomes of the Mindful Peer Coach program using participant surveys, app-use data, peer-coach training, coaching sessions, weekly text-message check-ins, and exit interviews with survivors and coaches.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • New Jersey
      • Nutley, New Jersey, Forenede Stater, 07110
        • HMH Center for Discovery and Innovation
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 39 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • at least one year from treatment completion
  • ability to speak conversational English,
  • per self-report, not being treated for posttraumatic stress disorder (PTSD), psychosis, or epilepsy/seizures.
  • have experience with mindfulness and/or be willing to attend training and supervision sessions (only for coaches)
  • at least two years from treatment completion (only for coaches) ;

Exclusion Criteria:

  • outside age range
  • closer to treatment completion than specified above

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindful Peer Coaching

Mindful Peer Coach consists of 1) live virtual and 2) text message coaching.

Participants will complete six structured weekly videoconference sessions designed to cultivate mindfulness practice and increase engagement with the Happier Meditation app.

Each session follows a standardized framework outlined in the training manual to ensure consistency and fidelity.

Between sessions, coaches will provide support and accountability via text messaging. The frequency of messages will be determined collaboratively during Session 1.

Each exchange begins with a previously tested mindfulness message, followed by tailored responses to reinforce practice, address questions, and sustain engagement.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Minutes use per day (User engagement)
Tidsramme: Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase

Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase
Number of days used per week (User engagement)
Tidsramme: Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.

Number of days used per week with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.
Depression
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Depression symptoms will be assessed using the PROMIS Depression measure. PROMIS Depression is an 8-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Anxiety
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Anxiety symptoms will be assessed using the PROMIS Anxiety measure. PROMIS Anxiety is an 7-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Mindfulness
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Mindfulness will be assessed using the Mindful Attention Awareness Scale measure. Your score falls into a range of 1 to 6, calculated by taking the average of all 15 responses. Higher average scores indicate greater overall mindfulness.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Emotion Regulation
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Emotion Regulation will be assessed using the emotional experience subscale from the Emotion Regulation Questionnaire (ERQ) measure. The Emotion Regulation has 6 items on a 7-point Likert scale, with 1 indicating "strongly disagree" and 7 indicating "strongly agree" ranging from 6 to 42 (computed as the mean of the 6 items). Higher scores indicate a greater tendency to alter how you think about a situation to change its emotional impact.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Positive and Negative Emotions
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Positive and Negative Emotions will be assessed using I-PANAS-SF (International Positive and Negative Affect Schedule Short-Form). It is a 10-item psychological tool that assesses affect. It evaluates both Positive Affect and Negative Affect on two separate 5-item subscales. Each of the 10 emotions is rated on a 5-point Likert scale, resulting in score ranges of 5 to 25 for both the Positive and Negative subscales. Higher scores indicate higher levels of that specific effect.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Distress
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Distress will be assessed using the Perceived Stress Scale. The Perceived Stress Scale (PSS-10) is a 10 item scale that has a total score range from 0 to 40, with higher scores indicating higher levels of perceived stress.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Overall Wellbeing
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Overall Wellbeing will be assessed using the PROMIS Global Health scale. For the standard PROMIS Global Health (PROMIS-GH-10) assessment, the 10 items produce two distinct summary scales: Global Physical Health and Global Mental Health. Because both subscales are made up of 4 items measured on a 1-5 point scale, the raw score range for each subscale is 4 to 20. While raw scores are simply the sum of your responses, they are not used directly to interpret health status. Instead, raw scores are converted into standardized T-scores using an established lookup algorithm:

A T-score of 50 represents the average health of the U.S. general population. Every 10 points away from 50 equates to one standard deviation. Higher T-scores indicate better self-reported health, regardless of whether it is the physical or mental subscale.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Disturbance
Tidsramme: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Sleep Disturbance will be assessed using the PROMIS Sleep Disturbance scale. The raw score range for the PROMIS Sleep Disturbance Scale 4-Item Short Forms: is generally 4 to 20. Higher raw scores correspond to a greater severity of sleep disturbance. These raw scores are then converted into a standardized T-score (where the general U.S. population average is 50, with a standard deviation of 10) using PROMIS Standardized Lookup Tables.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exit Interview
Tidsramme: At the end of the 8-week intervention period

Qualitative feedback collected through semi-structured exit interviews; no quantifiable data will be generated. Themes will be identified and presented using descriptive statistics.

At the end of the 8-week intervention period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Gary Kwok, PhD, Hackensack Meridian Health Center for Discovery and Innovation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. december 2026

Primær færdiggørelse (Anslået)

14. december 2029

Studieafslutning (Anslået)

15. marts 2030

Datoer for studieregistrering

Først indsendt

17. september 2026

Først indsendt, der opfyldte QC-kriterier

17. september 2026

Først opslået (Faktiske)

23. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Pro2024-0069
  • K01CA308858 (U.S. NIH-bevilling/kontrakt)

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